Summary for ARTG Entry:
St Jude Medical Australia Pty Ltd - CPS Direct Universal Slittable Outer Guide Catheter - Catheter, cardiac,
ARTG entry for
Medical Device Included Class III
St Jude Medical Australia Pty Ltd
17 Orion Road,LANE COVE, NSW, 2066
ARTG Start Date
Medical Device Class III
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
St Jude Medical Cardiac Rhythm Management
15900 Valley View Court
Sylmar, California, 91342
United States Of America
1. CPS Direct Universal Slittable Outer Guide Catheter - Catheter, cardiac, ventricular
Single Device Product
17613 Catheter, cardiac, ventricular
The catheter is used to facilitate left heart lead delivery during CRT procedures. The catheter provides
access to the coronary venous system and act as a conduit for contrast medium, implantable coronary
leads or other devices. The package includes 1 outer catheter, 1 dilator and 2 valve bypass tools.
The CPS Direct Universal slittable outer guide catheter is designed for intracardiac access of the venous
system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and
St Jude Medical devices (including implantable left heart leads and delivery tools), and support of fluids
where minimising blood loss is essential. In addition, the catheters can work with inner catheters as a
Shape (of tip) Extra Wide
Shape (of tip) Straight
Shape (of tip) Wide
Shape (of tip) 115°
Length (cm) 47-54
Shape (of tip) Right Side
Shape (of tip) 135°
No Specific Conditions included on Record
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Produced at 10.11.2017 at 08:17:02 AEDT
This is not an ARTG Certificate document.
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